Shockwave CS Guide Catheter

FDA UDI

Class II (US FDA UDI)

by Shockwave Medical, Inc.

Identity

Trade Name: Shockwave CS Guide Catheter FDA UDI
Generic Name: Vascular guide-catheter, single-use FDA UDI
Device Name: The Shockwave CS Guide Catheter is a single lumen 9F catheter consisting of a PTFE liner, stainless steel braid, and polymer outer jacket. The transition segments of the catheter have a gradual decrease in stiffness starting from the proximal shaft segment and ending at the distal tip. The Shockwave CS Guide Catheter features a pre-shaped curved distal shaft with radiopaque tip. The proximal end of the guide catheter has a standard luer fitting for connecting to a hemostasis valve. The proximal luer also includes a curve indicator to match the direction of the guide catheter tip curvature and provides a tactile and visual cue to the user. FDA UDI
Model / Reference: Shockwave CS Guide Catheter FDA UDI
Description: The Shockwave CS Guide Catheter is a single lumen 9F catheter consisting of a PTFE liner, stainless steel braid, and polymer outer jacket. The transition segments of the catheter have a gradual decrease in stiffness starting from the proximal shaft segment and ending at the distal tip. The Shockwave CS Guide Catheter features a pre-shaped curved distal shaft with radiopaque tip. The proximal end of the guide catheter has a standard luer fitting for connecting to a hemostasis valve. The proximal luer also includes a curve indicator to match the direction of the guide catheter tip curvature and provides a tactile and visual cue to the user. FDA UDI

Identifiers

Catalog Number: SWCSGC01 FDA UDI
Primary DI / UDI-DI: 00195451000836 FDA UDI
510(k) Number: K243757 FDA UDI
FDA Product Code: DQY FDA UDI
GMDN Term: Vascular guide-catheter, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1250 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.1 Millimeter FDA UDI
Lumen/Inner Diameter — 2.59 Millimeter FDA UDI
Catheter Working Length — 61 Centimeter FDA UDI
Introducer Sheath Compatibility — 9 French FDA UDI

Category: Vascular guide-catheter, single-use

Shockwave CS Guide Catheter by Shockwave Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Vascular guide-catheter, single-use.

Launcher — MEDTRONIC, INC. · Class II
Launcher™ — MEDTRONIC, INC. · Class II
SHERPA NX BALANCED — MEDTRONIC, INC. · Class II
Surefire Guiding Catheter — Surefire Medical, Inc. · Class II
SHERPA NX BALANCED™ — MEDTRONIC, INC. · Class II
Zebra — QApel Medical, Inc. · Class II
Mach1™ — Boston Scientific · Class II
SHERPA NX BALANCED — MEDTRONIC, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Shockwave Medical, Inc.

Sources (1)

FDA UDI 354343d6-0013-4d5f-ad3b-aa3536daee8a 38 fields · synced Jun 6, 2026